Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
Our PharmEng professionals have extensive experience in the development, implementation and execution of:
- Enhanced Detail Design Reviews – Design Qualification (DQ)
- User Requirements Specifications (URS)
- Functional Specifications (FS)
- Risk Management Tools
- Commissioning / Qualification / Validation Master Plans
- Project Management Tools (Budgeting, Scheduling, Tracking, Resource Planning)
- Facility / Utility System Commissioning Test Procedures
- Critical Utility System Qualification (IQ/OQ/PQ) Protocols
- Process Equipment and Process System Qualification (IQ/OQ/PQ) Protocols
- Controlled Temperature Units(IQ/OQ/PQ) Protocols
- Process Control Systems(IQ/OQ/PQ) Protocols
- Packaging Lines(IQ/OQ/PQ) Protocols